(137 days)
Not Found
No
The description details standard oscillometric blood pressure measurement, irregular heartbeat detection based on simple thresholding, data storage, averaging, classification based on standard guidelines, voice broadcast, and Bluetooth transmission. None of these functions inherently require or suggest the use of AI or ML. The irregular heartbeat detection is explicitly defined by a simple percentage deviation threshold.
No
The device is used for measuring blood pressure, not for treating a disease or condition.
Yes
Explanation: The device is intended to measure systolic and diastolic blood pressure and pulse rate, which are physiological measurements used for diagnostic purposes. It also includes features like irregular pulse rhythm detection and blood pressure classification, which provide information relevant to a medical diagnosis.
No
The device description clearly outlines hardware components such as an inflatable cuff, batteries, USB port, and a physical unit that performs oscillometric measurements and stores data. While it has Bluetooth functionality for data transmission, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is an Upper Arm Electronic Blood Pressure Monitor. It measures blood pressure and pulse rate using a non-invasive technique (a cuff on the arm). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, not to perform diagnostic tests on biological samples.
- Device Description: The description details the mechanical and electronic operation of the device for measuring blood pressure, not for analyzing biological samples.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x90 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2x90 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.
The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.
The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP100 and FC-BP110 applied).
There is a maximum pressure safety setting at 300 mmHq, when the pressure is more than 300mmHg, the device will exhaust fast automatically.
No operation for 1 minute the device will shut down automatically.
The device includes model FC-BP100.FC-BP101.FC-BP102.FC-BP110. FC-BP111. FC-BP112,they are same except the appearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
Household
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical trials for the Upper Arm Electronic Blood Pressure Monitor were performed according to the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type. 138 subjects were selected to participate in the trial. Auscultation was applied as the gold standard with a qualified calibrated mercurial sphygmomanometer used as the control group for comparison with the subject device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Trial: The clinical trials for the Upper Arm Electronic Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.
Sample Size: 138 subjects.
Key Results: The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±5mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ± 3 mmHg (for BP Accuracy), ± 5% of reading value (for Pulse Accuracy)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2022
Shenzhen Finicare Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 CHINA
Re: K220113
Trade/Device Name: Upper Arm Electronic Blood Pressure Monitor (Models FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 21, 2022 Received: April 27, 2022
Dear Boyle Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Upper Arm Electronic Blood Pressure Monitor(Model:FC-BP100,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
Indications for Use (Describe)
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K220113
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Shenzhen Finicare Co., Ltd. |
|---|---|
| Address: | 201, No.50, the 3rd Industrial Park, Houting Community |
| Shajing Street, Bao'an District, Shenzhen 518104 China | |
| Tel: | 86-755-23013503 |
| Contact: | Chao Li |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, |
| 200120 China | |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: May.29,2022
2.0 Device Information
| Trade name: | Upper Arm Electronic Blood Pressure Monitor |
|---|---|
| Common name: | Noninvasive Blood Pressure Measurement System |
| Classification name: | Noninvasive Blood Pressure Measurement System |
| Model(s): | FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111 |
| FC-BP112 | |
| Production code: | DXN |
| Regulation number: | 21 CFR 870.1130 |
| Classification: | Class II |
| Panel: | Cardiovascular |
3.0 Predicate Device Information
Manufacturer: Truly Instrument Limited Trade name: Arm Blood Pressure Monitor,Model: DB66-1, DB68
4
510(k) number: K192023
4.0 Indication for Use Statement
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
5.0 Device Description
The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x90 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2x90 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement.
This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.
The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.
The device features a built-in "Bluetooth Data Transmission" function, which enables
5
the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP100 and FC-BP110 applied).
There is a maximum pressure safety setting at 300 mmHq, when the pressure is more than 300mmHg, the device will exhaust fast automatically.
No operation for 1 minute the device will shut down automatically.
The device includes model FC-BP100.FC-BP101.FC-BP102.FC-BP110. FC-BP111. FC-BP112,they are same except the appearance.
6.0 _Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 80601-2-30:2018, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers.
EN 300328:2019 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques.
301489-1:2019 ElectroMagnetic Compatibility (EMC)standard for radio EN equipment and services;Part 1:Common technical requirements.
EN 301489-17:2020 Electromagnetic compatibility and Radio spectrum Matters
(ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems.
EN 62479:2010 Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields (10 MHZ to 300 GHZ )
IEC 62304:2015 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.
7.0 Clinical Test Conclusion
6
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Upper Arm Electronic Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 138 subjects been selected to participate in the trial, and Auscultation applied as gold standard with the qualified calibrated mercurial was was was and sphygmomanometer used as control group for comparison with the subject device.
The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±5mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared.
8.0 Technological Characteristic Comparison Table
7
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device | ||
| K220113 | Predicated Device | ||
| K192023 | Remark | ||
| Manufacturer | Shenzhen Finicare Co., Ltd. | Truly Instrument Limited | / |
| Product Name | Upper Arm Electronic Blood | ||
| Pressure Monitor: | |||
| FC-BP100,FC-BP101,FC-BP102, | |||
| FC-BP110,FC-BP111, | |||
| FC-BP112 | Arm Blood Pressure Monitor | ||
| DB66-1, DB68 | / | ||
| Product Code | DXN | DXN | SE |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | SE |
| Class | II | II | SE |
| Intended | |||
| Use/Indication | |||
| for Use | Upper Arm Electronic Blood | ||
| Pressure Monitor, Models FC- | |||
| BP100,FC-BP101,FC-BP102,FC- | |||
| BP110,FC-BP111,FC-BP112 are | |||
| intended to measure the systolic | |||
| and diastolic blood pressure and | |||
| pulse rate of an adult individual by | |||
| using a non-invasive technique in | |||
| which an inflatable cuff is | |||
| wrapped around the upper arm. | |||
| The devices' features include | |||
| irregular pulse rhythm detection | |||
| during measurement, and will | |||
| display a alert signal with the | |||
| reading when irregular heartbeat | |||
| is detected. | |||
| The devices' feature includes | |||
| Bluetooth function to transmit | |||
| data to an external Bluetooth | |||
| device with wireless | |||
| communication. | Automatic Arm Blood Pressure | ||
| Monitor DB series, Models | |||
| DB66-1, DB68 are a series | |||
| devices intended to measure | |||
| the systolic and diastolic blood | |||
| pressure and pulse rate of an | |||
| adult individual by using a non- | |||
| invasive technique in which an | |||
| inflatable cuff is wrapped | |||
| around the upper arm. | |||
| The devices' features include | |||
| irregular pulse rhythm | |||
| detection during measurement, | |||
| and will display a alert signal | |||
| with the reading when irregular | |||
| heartbeat is detected. | |||
| The devices' feature include | |||
| Bluetooth function to transmit | |||
| data to an external Bluetooth | |||
| device with wireless | |||
| communication. | SE | ||
| Application Site | Upper Arm | Upper Arm | SE |
| Cuff | |||
| Circumference | 22-42cm | Not Publicly available | Different |
| Patients | |||
| Contacting | |||
| Materials | Patient contact materials of the | ||
| cuff: 210D Nylon TPU | |||
| According to ISO-10993 | Cuff | ||
| According to ISO-10993 | SE | ||
| Patient | |||
| Population | Adult | Adult | SE |
| Measurements | |||
| Item | SYS,DYS,Pulse | SYS,DYS,Pulse | SE |
| Display | LCD Digital Display | Liquid crystal display | SE |
Table1-General Comparison
Table 2 Performance Comparison
| ltem | Subject Device | Predicate Device
K192023 | Remark |
|----------|----------------|-----------------------------|--------|
| Max Cuff | 300mmHg | 300mmHg | SE |
8
| pressure | |||
|---|---|---|---|
| BP Range | 0-299 mmHg | 20 ~ 280 mmHg | Different |
| BP Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | SE |
| PR Range | 40-180 beats/min | 40 ~ 195 beats/min | Different |
| Pulse Accuracy | $\pm$ 5% of reading value | $\pm$ 5% of reading value | SE |
| Irregular heartbeat detection | More than $\pm$ 25% to the mean interval of pulse intervals. | More than $\pm$ 25% to the mean interval of pulse intervals. | SE |
| Inflation Method | Automatic inflation by pump | Automatic internal pump | SE |
| Deflation Method | Automatic rapid deflation | Automatic deflation | SE |
| Memory Size | 2x90 set of data | 99 set | Different |
| Operation Condition | 10~40℃ | ||
| 15~85%RH | 10~40℃, | ||
| 15~90%RH | Different | ||
| Storage Condition | -20~55 °C | ||
| 0~95% RH | -20℃~60℃, | ||
| 10%~95%RH | Different | ||
| Performance Standard | Comply with IEC 80601-2-30 | Comply with IEC 80601-2-30 | SE |
| Power Supply | 4 AA batteries or DC6V, or USB Type C (DC5V1A) | Polymer battery DC3.7V, 500mAh. | |
| Or 4x 1.5V AA Battery | Different |
Analysis:
The subject and predicate device have same general intended use, similar design features and performance specifications.
The differences in BP Range, PR Range and Memory Size do not raise different questions of safety or effectiveness since the device complied with the requirement of IEC 80601-2-30.
The differences in Operation Condition and Storage Condition between both devices are insignificant in terms of safety and effectiveness. Also, the little difference in power supply according to the Electrical Safety and EMC test result, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. So we think the subject device is substantially equivalent to the predicate device.
| Item | Proposed Device | Predicate Device
K192023 | Remark | | | |
|-------------------|---------------------------------------|--------------------------------------|--------|--|--|--|
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE | | | |
| Home Use | Comply with IEC 60601-1-
11 | Comply with IEC 60601-1-11 | SE | | | |
| EMC | Comply with IEC 60601-1-
2 | Comply with IEC 60601-1-2 | SE | | | |
| FCC conformity | FCC 47 part 15 subject B | FCC 47 part 15 subject B | SE | | | |
| ERM conformity | EN 301489-1:2017:
EN301489-17:2017 | EN301489-1:2017:
EN301489-17:2017 | SE | | | |
| RF conformity | EN300328:2016 | EN300328:2016 | SE | | | |
Table 3 Safety Comparison
9
| Health | EN62479:2010 | EN62479:2010 | SE |
|---|---|---|---|
| Biocompatibility | Comply with ISO 10993-1, | ||
| FDA Guidance | Comply with ISO 10993-1, FDA | ||
| Guidance | SE |
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.